System, apparatus and methods for recognizing surgical articles left inside patients

ABSTRACT

System, methods and apparatus related to surgical articles used during surgery. The system, methods and apparatus may include features such as an element/substrate added to surgical articles which enables the recognition by human visualization of the surgical articles when left inside patient bodies when viewed with medical imaging technologies. The element/substrate may include a plurality of three dimensional objects. Alternatively, the element/substrate may comprise a ribbon of radiopaque material having cut-puts or other radiolucent regions which provide image artifacts observable under fluoroscopic imaging.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional of U.S. patent application Ser. No.16/000,667 (Attorney Docket No. 50536-703.201), filed Jun. 5, 2018 (nowU.S. Pat. No. ______), which claims the benefit of provisionalapplication No. 62/515,856 (Attorney Docket No. 50536-703.102), filed onJun. 6, 2017, the full disclosure of which is incorporated herein byreference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates generally to surgical articles used duringsurgery. More particularly, the present invention relates to therecognition of surgical articles located inside a patient's body byhuman visualization of medical imagining technologies.

During a surgical procedure it is generally necessary for surgicalarticles to be placed into or around the patient's surgical incisionsite. Such articles may include surgical instruments, towels, spongesand the like. Before, during and after surgical procedures surgicalteams go to great efforts to account for all the surgical articles usedduring that surgery in an attempt to avoid one or more of those itemsbeing inadvertently left inside a patient. Patient morbidity associatedwith unintentionally retained surgical articles can range from infectionto mortality and the financial implications can be substantial.

Due to a number of factors surgical articles made of fabric or fabriclike materials, such as surgical sponges and towels, prove particularlydifficult to account for during and after surgery. Accordingly, thesetypes of surgical articles account for the majority of itemsinadvertently left inside patients. Surgical sponges and towels arecommonly used during surgical procedures to absorb body fluids, mostlyblood, of the patient both inside the incision and around the surgicalsite. These surgical items are usually made of flexible, absorbentfabric or fabric like material such as cotton and are oftenintentionally or unintentionally folded one or more times during use.Additionally, when saturated with blood these items alter in size andshape and therefore become hard to distinguish from body tissue and eachother.

In an effort to avoid unintentionally leaving surgical articles insidepatients after surgery, surgical teams routinely count all theindividual items before and after each surgery. If the count of theseitems taken after a surgical procedure does not match the count prior tothat procedure, efforts are made to find the missing item or items untilthe counts match. Additionally, surgical articles intended to be placedinside the patient or around the surgical incision commonly include anx-ray detectable element. In the event one or more surgical articlescannot be accounted for, x-ray technology is commonly utilized in aneffort to aid surgical teams in finding the missing item or items or toconclude the missing item or items are not inside the patient.

Increasingly, additional technologies including barcoding, radiofrequency and radio frequency identification are being utilized bysurgical teams to assist them in counting and accounting for surgicalarticles, however it is still common and desirable for these solutionsto further incorporate x-ray detectable elements in their articles in aneffort to provide a confirmatory or backup methodology for locating alost item or items and confirming no items are inside a patient.

Surgical articles made of fabric or fabric like materials, such assurgical sponges and towels, commonly include an elongated radiopaquethread like element designed to be recognized when viewed with x-rayfluoroscopy. Despite the presence of thread like radiopaque elements,surgical articles made of fabric or fabric like materials, such assurgical sponges and towels, are commonly missed by individuals trainedto recognize such items with medical imaging technologies andinadvertently left inside patients. In a study entitled “Incidence andCharacteristics of Potential and Actual Retained Foreign Object Eventsin Surgical Patients” (Cima et al, Incidence and Characteristics ofPotential and Actual Retained Foreign Object Events in SurgicalPatients, Journal of the American College of Surgeons, 12/2007, pages80-87), in 33% of patients where intra-operative x-rays were utilizedthe retained surgical article was mistakenly not recognized. In anotherstudy entitled “Retained Surgical Items: An Problem Yet to be Solved”(Stawicki et al, Retained Surgical Items: A Problem Yet to Be Solved,Journal of the American College of Surgeons, 8/2012, pages 15-22) in 48%of retained sponge cases the sponges were missed on initial x-rayinterpretation.

There are a multitude of reasons a thread like element attached tosurgical articles made of fabric or fabric like material such as asurgical sponge or towel intended to be recognized with humanvisualization on medical imaging technologies can be missed. One reasonmay be that the article and element was folded one or more times makingthe x-ray element more difficult to see. Another reason may be that thex-ray thread element is mistakenly thought to be a wire or wire likeitem, as wires and wire like items are often placed in and around apatient at the time an x-ray may be taken. Examples include wires andwire like items from devices intentionally left inside patientsincluding pain management devices, defibrillators and pacemakers as wellas tubes or wires from items placed on top of the patientpost-operatively such as IVs, and wires from various life support andpatient monitoring devices. Another reason may be the image taken of thearticle is captured at an angle such that the 2 dimensional nature ofthe thread like x-ray element is more difficult to see or appearssimilar to another object. Another reason may be that the image taken ofthe article is taken at a particular cross section of the thread likeelement such that the 2 dimensional nature of the thread like elementdoes not appear to be a thread like element. This may be particularly anissue when newer or more advanced imaging technologies are utilized thatare capable of taking an image of a specific depth or cross section ofthe patient as opposed to an image of the patient in their entirety.Such imaging technologies may include magnetic resonance imaging orultrasound imaging. Another reason that a thread like x-ray element maybe missed is that when an x-ray is taken of a moving patient, such aswhen the target area is the abdomen and the patient is breathing, anx-ray element will sometimes appear blurred or smeared and thus may bemisinterpreted as something other than a thread like x-ray element.

For these reasons it would be desirable to provide alternative andimproved systems, methods and apparatus for the recognition of surgicalarticles left inside of patients. In particular, it would be desirableto provide alternative systems, methods and apparatus for improving theability to recognize surgical articles left inside of patients usinghuman visualization of those items with medical imaging technologies,including both x-ray and other imaging technologies.

2. Background of the Prior Art

U.S. Pat. No. 7,465,847 discloses the use of spherical radiopaquemarkers to aid in the visual recognition of surgical sponges, howeverthere are considerable differences between the invention disclosed inthe '847 patent and the present invention and the present inventionaffords significant advantages over the product disclosed in the '847patent. The product disclosed in the '847 patent utilizes apredetermined number of specifically three spherical markers on eachsurgical sponge and those three spherical radiopaque markers are closelygrouped, proximate and directly contiguous to one another. The presentinvention utilizes a plurality of three dimensional objects, includingpotentially spherical shapes, however unlike the '847 patent the presentinvention utilizes a plurality of three dimensional shapes in a fashionwherein those objects are intentionally not closely grouped, proximatenor directly contiguous to one another. Further unlike the '847 patent,the present invention utilizes a plurality of three dimensional objects,the exact number of which on each article/sponge is not predetermined.Further, the plurality of objects of the present invention are tetheredtogether with a flexible material that intentionally creates spacesbetween each object, hence they are not closely grouped together, arenot proximate to each other and not directly contiguous to one another.Further, the present invention includes those connected/tethered objectsand the connecting material throughout the entire length of at least oneside of the surgical article. Advantages of the approach of the presentinvention as compared to the '847 patent include: (1) because thesubstrate runs at least the entire length of at least one side of thearticle, substantially more three dimensional objects can be included ineach article, increasing the probability of recognition by humanvisualization on medical imaging, (2) because the plurality of threedimensional objects are not proximate nor directly contiguous to oneanother and are instead spaced out and tethered with a flexiblematerial, the resulting substrate allows for the inclusion of thoseobjects along at least one side of the article without compromising theclinically desired flexible nature of the fabric or fabric like materialof the surgical article, (3) because the plurality of three dimensionalobjects are spaced out and connected with a flexible material, thatflexible tethering/connecting material can be used not just totether/connect the objects but also to adhere the objects to the fabricor fabric like material of the surgical article in an effective and costeffective manner. This can be done by utilizing a flexibletethering/connecting material that either binds to the fabric or fabriclike material through the application of heat and pressure (being meltedand pressed into the fabric or fabric like material) or by sewing thetethering/connecting material to the fabric/fabric like material.

U.S. Pat. Nos. 6,777,623 and 7,001,366 (a continuation of the '623patent) disclose the use of radiopaque objects to count and account ofsurgical sponges, however there are considerable differences between thetwo inventions disclosed in the '623 and '366 patents and the presentinvention and the present invention affords significant advantages overthe product disclosed in the '623 and '366 patents. The productdisclosed in the '623 and '366 patents utilizes exactly oneradiographically detectable object affixed to each individual surgicalarticle and depends on this approach to obtain an accurate count of eacharticle. Further, a separate scanning device is utilized that can detectand count a large number of the objects, one on each sponge, within acontainer. Unlike the '623 and '366 patent, the present inventionutilizes a plurality of three dimensional objects tethered together andincluded with each individual surgical article and further that thoseconnected/tethered objects run at least the length of one side of thesurgical article. Additionally, the plurality of objects included witheach surgical article in the present invention are adapted to berecognized by human visualization when viewed with medical imagingtechnology whereas the '623 patent specifically describes the use of ascanning device coupled with a counting device utilizing non-human meansfor counting each sole object on each surgical sponge. Advantages of thepresent invention as compared to the '623 and '366 patent include: (1)because the '623 and '366 patent utilizes a non-human counting mechanismand a scanning device and a container the invention is considerably moreexpensive to implement than the present invention, (2) unlike the '623and '366 patent invention which utilizes exactly one radiopaque objecton each surgical article, the present invention includes a plurality ofthree dimensional objects designed to be recognized by humanvisualization, as such the probability of the human recognition of saidobjects when viewed on medical imaging technologies is higher, (3) the'623 and '366 patents disclose that by using the invention as described“a surgical team can insure that no surgical sponge is left in a patientwithout performing the messy and time-consuming job of individuallycounting sponges as they are entered and disposed of from the surgicalsite”, whereas the current invention makes no attempt to replace themanual counting process of these items; doing so creates a soledependency on every facet of the technology to perform correctly, andfor there not to be any human user error in any step in the process, andthus opens up the safety of the patient to incremental technology anduser error risk.

US2015245955 describes surgical gloves having RO markers which are“readily recognizable and differentiated from the images produced byother items and structures commonly seen in x-rays.”

U.S. Pat. No. 7,465,847 shows individual stars, diamonds or other ROpatterns which are individually attached to a sponge. In FIG. 4, adiamond-shaped marker 18 is mounted on what appears to be an RFID tag20.

U.S. Pat. No. 7,001,366 shows a surgical sponge having RO beads on apatch but does not show an elongate ribbon (it does use the word tape atcol. 5, line 57) and not multiple beads or other objects on a singlepatch.

U.S. Pat. No. 4,244,369 shows a surgical sponge having a thermoplastic“elongated ribbon” which is stitched to a sponge. The ribbon does notdefine distinct image artifacts.

U.S. Pat. No. 3,965,907 shows an RO polymer which is patterned in situon a sponge to have a unique thickness/width pattern to enhancerecognition. It is not pre-formed and does not have individual stars orother shapes formed by RO/radiolucent regions.

SUMMARY OF THE INVENTION

The present invention provides apparatus, systems and methods forimproved recognition of surgical articles left inside patients. Aplurality of three dimensional objects contain material making them moreeasily recognized with human visualization when using medical imagingtechnologies are included in each surgical article. Such imagingtechnologies may include x-ray, ultrasound or magnetic resonanceimaging. Such material may include barium sulfate (BaSO₄). In anotherembodiment, the three dimensional objects will be comprised entirely ofmaterials making them more easily recognized with human visualizationwhen using medical imaging technologies. Such materials may includesteel, titanium or another alloy. The three dimensional objects may beshaped such that they appear in substantially the same shape when viewedat various angles and at various cross sections. Such shapes mayspherical.

In one embodiment the plurality of three dimensional objects aretethered or otherwise connected together with a flexible material. Asused herein, the term “tethered” will means that the three dimensionalobjects will be connected by some form of a flexible, elongate member,typically a filament, fiber, thread, suture, wire, or similarstring-like element where the individual three dimensional objects areformed integrally with, strung over, or otherwise coupled to theflexible elongate member. Alternatively, three dimensional objects maybe tethered together in a sleeve or other tubular structure. The threedimensional objects may be tethered together by: (i) the same materialcomprising the objects, (ii) through another material or (iii) by thoseobjects being included in or on a substrate. Usually, the materialconnecting the three dimensional objects will contain a material thatenable those objects to be recognized on medical imaging technologiesthrough human visualization. Such material may include barium sulfate(BaSO₄).

In one embodiment one of the plurality of tethered/physically connectedthree dimensional objects is spaced from another in a substantiallysimilar distance. In another embodiment two or more three dimensionalobjects clustered together in relatively close proximity to each otherare spaced out from another group of two or more three dimensionalobjects clustered together in relatively close proximity to each otherin a substantially similar distance.

In one embodiment one of the plurality of three dimensional objectson/in a substrate is spaced from another on or in a substrate in asubstantially similar distance. In another embodiment two or more threedimensional objects clustered together in relatively close proximity toeach other on/in a substrate are spaced out from another group of two ormore three dimensional objects clustered together in relatively closeproximity to each other in a substantially similar distance on/in thesubstrate.

In one embodiment, the plurality of tethered three dimensional objectsare attached to a surgical article comprised of fabric or fabric likematerial across the substantially the entire length of one or moresides. In exemplary embodiments the tethered three dimensional objectsare attached to a single layer of continuous fabric or fabric likematerial in a continuous manner, then the fabric or fabric like materialmay be then be cut into individual pieces then further may be folded oneor more times. In exemplary embodiments the material connecting thetethered three dimensional objects can be of a material that at leastpartially melts when heat is applied such that the connecting materialmelts to adhere to the fabric or fabric like material. Such material maybe at least partially composed of a heat-meltable polymer. In anotherembodiment the material connecting the tethered three dimensionalobjects may be sewn directly to the fabric or fabric like material.

In another embodiment the substrate with the objects on or in it isattached substantially the entire length of one or more sides of asurgical article comprised of fabric or fabric like material. Inexemplary embodiments the substrate is attached to a single layer ofcontinuous fabric or fabric like material in a continuous manner thenthe fabric or fabric like material may be then cut into individualarticles then further may be folded one or more times. In exemplaryembodiments the substrate can be at least partially of a material thatat least partially melts when heat is applied such that the substratemelts to adhere to the fabric or fabric like material. Such material maybe at least partially composed of a heat-meltable polymer. In anotherembodiment the substrate may be sewn directly to the fabric or fabriclike material.

In one embodiment the surgical articles may be made of fabric or fabriclike material, the color of the absorbent material being one that, whensoaked with blood contrasts with the color of blood. Such color may beblue or green.

In a first particular aspect of the present invention, a surgicalarticle comprises a sheet of an absorbent fabric material configured toabsorb body fluid. A first plurality of discrete radiopaque elements aredistributed over at least one distribution line of extending from oneedge of the sheet to another edge of the sheet, where the firstplurality of discrete radiopaque elements are arranged in a tetheredconstruct which is attached to the sheet of the absorbent fabricmaterial.

The tethered construct typically comprises a flexible elongate memberwhere the plurality of discrete radiopaque elements are formedintegrally with or secured to the flexible elongate member. For example,the flexible elongate member can be a filament, fiber, thread, suture,wire, or similar string-like element where the individual radiopaqueelements are strung over the flexible elongate member. In suchconstructs, the filament, fiber, thread, suture, wire, like, willusually be formed separately from the discrete radiopaque elements, andthe radiopaque elements will be attached over the elongate member usingadhesives, by crimping, by applying a combination of heat and pressureor by other conventional techniques.

Alternatively, the tethered construct may be molded to form both theplurality of discrete radiopaque elements and the flexible elongatemember into a single integrated or “monolithic” unit. In such cases, theelongate member and the radiopaque elements will typically be formedfrom the same material although the amount of a radiopaque filler couldvary with the radiopaque elements typically having a higher radiopacity.Forming the entire tethered construct in a single fabrication processwill often be an efficient and preferred manufacturing approach.

In other embodiments, the flexible elongate member may comprise a sleeveor other tubular member where the plurality of the discrete radiopaqueelements are secured within an inner lumen or passage of the tubularmember. For example, tubular member may be a sock-like member with theradiopaque elements distributed within the interior of the sock.Usually, the radiopaque elements will be secured so that they are notable to move within the interior of the tubular member. For example,they can be glued, sutured, welded, or otherwise secured in place.

The tethered constructs will be attached to the sheet of absorbentfabric material by any one of a variety of techniques. For example, thetethered construct may be woven into the fabric, sutured to the fabric,welded to the fabric, heat sealed to the fabric, laminated to thefabric, or the like.

In the exemplary embodiments, the sheet of absorbent material isconfigured to be folded so that individual ones of the discreteradiopaque elements on one side of the fold will align in some desiredpattern with others of the discrete radiopaque elements on the otherside of the fold to enhance a radiopaque image artifact when the sheetis viewed under fluoroscopy or X-ray in its folded configuration. Forexample, the sheet may be configured to be folded into two halves alonga fold line where the distribution line of the radiopaque elementscrosses over the fold line so that some of the plurality of the discreteradiopaque elements are on one side of the fold line and others of theplurality of discrete radiopaque elements are on the other side of thefold line. In this way, when the sheet of absorbent material is folded,radiopaque elements on opposite sides of the fold line may stack overeach other in order to reinforce the radiopaque image artifact when theimage is scanned under fluoroscopy or x-rays. Alternatively, thediscrete radiopaque elements on one side of the fold line may beinterspersed between others of the discrete radiopaque elements on theother side of the fold line after folding. In this way, the lineardensity of the radiopaque elements is increased. In still otherembodiments, at least one distribution line is oriented at an acuteangle relative to the fold line so that the discrete elements on oneside of the fold line and those on the other side of the fold line areoriented in a V-shape relative to each other after the sheet is folded.In still other embodiments, the sheets may include two, three, four, oreven more distribution lines for the radiopaque elements.

In a second particular aspect of the present invention, a surgicalarticle comprises a sheet of an absorbent fabric material configured tobe folded and to absorb body fluid in the folded configuration. A firstplurality of discreet radiopaque elements is distributed over at leastone distribution line extending from one edge of the sheet to anotheredge of the sheet. Individual ones of the discrete radiopaque elementswill align with others of the discrete radiopaque to enhance aradiopaque image artifact when the sheet is in its folded configuration.

The absorbent fabric material may be any type of surgical absorbentmaterial, typically being a woven surgical sponge material. The twohalves of the sheet are typically folded at least once over a fold linewhere the at least one distribution line crosses over the fold line sothat some of the plurality of discrete radiopaque elements will be onone side of the fold line and others will be on the other side of thefold line after the article is folded. The fold line will typically bedisposed along a center or other line of symmetry of the absorbentmaterial but could in other instances be located asymmetrically. Also,note that the absorbent material may have more than one fold line sothat the article may be first folded along one fold line followed byfolding along a secondary fold line and optionally further fold lines.

The locations of the discrete radiopaque elements over the sheet ofabsorbent fabric material may be specifically chosen so that theradiopaque image artifact provided by the radiopaque elements is in someway enhanced after the sheet of material is folded one or more times.For example, the radiopaque elements on one side of a fold line maystack over or near others of the radiopaque elements on the other sideof the fold line after folding. Alternatively or additionally, theradiopaque elements on one side of the fold line may be interspersedbetween others of the radiopaque elements on the other side of the foldline after the absorbent fabric sheet is folded. Many other patterns arealso available. For example, at least one distribution line may beoriented at an acute angle relative to the fold line so that thediscrete radiopaque elements on one side of the fold line and thediscrete radiopaque elements on the other side of the fold line areoriented in a V-shape relative to each other after the sheet is folded.

The plurality of discrete radiopaque elements will typically be arrangedin a tethered construct where the tethered construct is attached to thesheet of absorbent fabric material. A number of different embodimentsfor such tethered constructs have been described above.

In alternative embodiments, the invention utilizes a ribbon or otherelongated substrate affixed to a surgical sponge, that substratecontaining radiopaque material, that substrate being shaped and appliedto the surgical sponge material in a fashion so as to improve the humanvisual recognition of said substrate (and hence the surgical sponge towhich it is affixed) when viewed on medical imaging technologies (with aprimary focus on x-ray). The substrate will be designed and shaped so asto: (1) provide meaningful visual contrast intended to “catch the eye”of those viewing the substrate on x-ray (as the shape will be designednot to look like any other object typically used in or around a patientin surgery), and (2) include distinct shaping used ubiquitously with theinvention to help identify the object as a surgical sponge (for examplethe ubiquitous use of a star shape). The radiopaque material used may bea material providing a higher radio-opacity (hence a brighter contrastunder x-ray) than barium sulfate, the material traditionally used withsurgical sponges.

In such alternative embodiments, the substrate will likely be affixed tothe sponge material either through sewing or through a heat pressprocess using a combination of heat, pressure and dwell time in order tomelt the substrate (or the layer contacting the sponge material) ontothe sponge material. The substrate will likely be affixed to the spongematerial either continuously to the sponge material (with the spongematerial then being cut and converted into a final sponge as a secondarystep) or as a discrete segment, i.e. a length or amount of substrateapplied to each sponge after formation of the sponge.

For example, any ribbon or other elongated substrates material may beapplied in a continuous fashion and affixed with a heat press process,e.g., the sponge material and the substrate may be placed through heatedrollers in a continuous fashion which applies the heat and pressure toaffix the substrate to the sponge material. If a discrete segment,length, or amount may be affixed with a heat press process, e.g. apre-cut segment of substrate may be placed in a desired attachmentposition on sponge material then a heat press applied directly over thesubstrate.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1C illustrate the radiopaque elements of the present inventionarranged in tethered constructs in different patterns, where theradiopaque elements are secured over a flexible elongate member.

FIGS. 2A-2C illustrate embodiments of the present invention where theradiopaque elements are secured inside of tubular flexible elongatemembers in order to form tethered constructs.

FIGS. 3A and 3B illustrate different techniques for fabricating surgicalarticles according to methods of the present invention.

FIG. 4 illustrates a first exemplary surgical article comprising a sheetof an absorbent fabric material having a tethered construct including aplurality of discrete radiopaque elements attached thereto.

FIG. 5 illustrates the surgical article of FIG. 4 partially folded alonga fold line to bring the discrete radiopaque elements into alignmentafter folding.

FIG. 6A illustrates a first exemplary of distribution of discreteradiopaque elements on the folded article of FIGS. 4 and 5.

FIG. 6B illustrates a second exemplary embodiment of a distribution ofdiscrete radiopaque elements on the folded surgical article of FIGS. 4and 5.

FIG. 7 illustrates a second embodiment of a surgical article constructedin accordance with the principles of the present invention having threedistribution lines including radiopaque elements where each distributionline has a different spacing pattern for the individual discreteradiopaque elements.

FIG. 8 illustrates a third embodiment of the surgical article of thepresent invention having a single distribution line including theplurality of radiopaque elements inclined at an acute angle relative tothe fold line.

FIG. 9 illustrates a fourth embodiment of a surgical article constructedin accordance with the principles of the present invention having aplurality of discrete radiopaque elements disposed in individual pocketsaligned along a single distribution line.

FIG. 10 illustrates a fifth embodiment of a surgical article constructedin accordance with the principles of the present invention having aplurality of discrete radiopaque elements sutured along a distributionline to a sheet of absorbent fabric material.

FIG. 11A illustrates an alternative radiopaque marker comprising aribbon of radiopaque material having portions which are cut-out intodistinct shapes.

FIG. 11B illustrates the radiopaque ribbon of FIG. 11A cut into shortersegments each of which includes portions which are cut-out into distinctshapes.

FIG. 12A illustrates a method for adhering a continuous length ofradiopaque ribbon identical or similar to that shown in FIG. 11A in aserpentine pattern to a continuous length of surgical gauze prior tocutting and formation into surgical sponges.

FIG. 12B illustrates the method and system of FIG. 12A shown from a topview.

FIG. 13 shows a surgical sponge with a straight segment of patterned,radiopaque ribbon on a surface there of before and after folding.

FIG. 14 shows a surgical sponge with a serpentine segment of patterned,radiopaque ribbon on a surface there of before and after folding.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIG. 1A, a first embodiment of a tethered construct 10includes a first plurality of radiopaque elements 12 distributed alongthe length of a filament 14. As used herein, the word “discrete” meansthat each radiopaque element exists as a unitary component having any ofthe dimensions and formed from any of the materials described elsewhereherein. Typically, the radiopaque elements 12 will be small sphereshaving a diameter in the range from approximately one (1) millimeter toseven (7) millimeters, preferable from approximately one and a half(1.5) millimeters to four (4) millimeters. When secured over a filament14, as illustrated in FIG. 1A, the radiopaque elements may have smallholes or passages allowing the filament to be threaded through theelement. Alternatively, the radiopaque elements may be integrally formedwith the filament by molding, extrusion, or other fabrication techniqueto form the tethered construct. Once each element is properly positionedon the filament, typically with a spacing in the range from five (5)millimeters to ten 100 millimeters, usually from ten (10) millimeters to25 millimeters, the elements will be fixed in place, e.g. by gluing,crimping, heat welding, or the like.

While the first embodiment of the tethered construct 10, as shown inFIG. 1A, has single radiopaque elements distributed evenly along itslength, the distribution pattern and spacing of radiopaque elementsalong a filament 14 may vary widely. For example, as show in FIG. 1B, asecond embodiment of a covered construct 16 may have pairs of radiopaqueelements 12 distributed along the length of a filament 14. When usingpairs of radiopaque element 12, the individual elements may be slightlysmaller than when using single radiopaque elements 12. Similarly, in thethird embodiment of a tethered construct 18 as show in FIG. 1C, theradiopaque elements 12 may be arranged in triplets, in which case fewerof the triplets or clusters of the elements may be needed. That is, ineach of the embodiments of FIG. 1A and 1B, there are six individual orclustered elements, in the tethered construct 18 of FIG. 1C, there areonly four total clusters on the filament 14. It will be appreciated, ofcourse, that the total number of individual radiopaque elements 12 orclusters of elements may vary widely with anywhere from 3 to 24, oftenfrom 4 to 10. Also, with regard to the embodiments of FIGS. 1A-1C, thefilament 14 may be any of the elongate, flexible tethers referred toabove, including fibers, threads, sutures, wires, and the like.

In each of the tethered constructs 10, 16 and 18 above, the radiopaqueelements 12 are formed separately from the filament. In otherembodiments, the radiopaque elements and filaments may be formed fromthe same material, typically a polymer loaded with a radiopaque filler.The tethered constructs may then be formed using convention polymerprocessing techniques, such as molding or extrusion.

Referring now to FIGS. 2A-2C, the tethered constructs of the presentinvention may rely on tubular or sleeve-like structures for containingthe individual or clustered radiopaque elements 12. For example, atethered construct 20 may include a sleeve or tube 22 having an interiorpassage or lumen 24 which can receive the individual or clusteredradiopaque elements 12. Referring specifically to FIG. 2A, theradiopaque elements 12 may be arranged as triplet four groups. As shownin FIG. 2B, there may be six paired radiopaque elements 12. Or as shownin FIG. 2C, there may be six individual radiopaque elements 12. In allcases, the radiopaque elements 12 may be immobilized within the tube orsleeve 22 using adhesives, clips, sutures, heat welding, or the like.The tubes, the sleeves themselves may be a fabric, polymer membrane, athin walled plastic tube or like.

Referring now to FIGS. 3A and 3B, any of the tethered constructsdescribed above may be secured to an absorbent fabric material asillustrated. For example, as shown in FIG. 3A, the absorbent materialmay be provided on a roll 30 while the tethered construct may beprovided on a roll 32 where the absorbent material and tetheredconstructs are drawn from the rolls and passed through a pair of opposedrollers 34 which may, for example, apply heat in order to seal thetethered construct onto the absorbent fabric material. After sealing,the fabric material having the attached covered construct may then betaken up on a roll 36 which may then be further processed in order toproduce individual surgical articles.

As shown in FIG. 3B, the fabric material having attached tetheredconstructs from roll 36 my be further processed into individual surgicalarticles, such as surgical sponges 50, by cutting the fabric materialinto desired lengths and configurations using a blade 38 or othercutting apparatus, such as laser cutting. Subsequently the individualpieces of material may be further folded or processed to convert thosesections of fabric to a desired final form.

Referring now to FIG. 4, a first exemplary surgical article 50 comprisesan absorbent fabric material 52, typically in the form of a square ofgauze or similar surgical sponge material. The tethered construct 10previously described may be secured to the absorbent fabric material 52,typically as shown in FIG. 3A prior to folding, so that the tetheredconstruct 10 lies along a distribution line which crosses a fold line 56which is typically at the center of the sponge.

As show in FIG. 5, the absorbent fabric material 52 may be folded aboutthe fold line 56 to draw opposed halves of the distribution line of theconstruct 10 together in order to align individual radiopaque elements12. The individual radiopaque elements 12 may be aligned so that theyare stacked or superimposed on each other so that they each contributeto a radiopaque artifact 12′.

As shown in FIG. 6A, stacking of the individual radiopaque elements 12will produce a greater radiopacity than the elements would withoutstacking. Alternatively, as shown in FIG. 6B, the individual radiopaqueelements 12 may be interspersed after the absorptive fabric material 52is folded so that the six individual radiopaque artifacts 12″ so thatthe image shows twice as many image artifacts over each individuallength (i.e., six image artifacts are visible over ½ of the originalwidth of the absorptive fabric material 52.

Referring to FIG. 7, a second exemplary surgical article 16 comprisesthree individual tethered constructs attached to the absorptive fabricmaterial 52. A first construct may be the same as any of the previouslydescribed constructs, for example, being construct 10. A second tetheredconstruct 64 may include a total of eight radiopaque elements 12 alongits distribution line. A third tethered construct 66 may include onlyfour radiopaque elements 12 along its length.

Referring now to FIG. 8, a third exemplary surgical article 70 includesa tethered construct 74 which includes a total of eight radiopaqueelements 12 along its distribution line. The distribution line whichlies along filament 14 is inclined at an angle alpha α relative to foldline 56. In this way, when the absorptive half brick material is foldedalong line 56, the resulting image artifact will be in a V-shape whenviewed under fluoroscopy or x-ray.

Referring now to FIG. 9, a fourth exemplary surgical article 80 includesa plurality of both individual radiopaque elements 12 disposed inindividual pockets 82 which are distributed along a distribution line84. The pockets will be sealed in order to contain the radiopaqueelements on the absorptive fabric material 82. The pockets 82 may bepart of the fabric material, e.g., being woven or sewn into the fabric.Alternatively, the pockets may be separately heat sealed or otherwiseadhere to a surface of the absorptive fabric material 52.

Referring now to FIG. 10, a fifth exemplary embodiment of a surgicalarticle constructed in accordance with the principles of the presentinvention comprises a plurality of individual radiopaque articles 12which are sutured using suture hoops 92 to the absorptive fabricmaterial. Radiopaque articles 12 having holes or passages through of thetype which may be placed over a filament can be used for the suturingembodiments.

In alternative embodiments, the ribbon or other elongated markersubstrate will typically comprise a custom compounded polymer havingcharacteristics which include: (1) radiopaque elements, components ormaterials of a nature and amount that can be visualized underfluoroscopy when present on the sponge as a thin film; (2) sufficientflexibility following extrusion, processing, and conversion to a finalformat to bend along with the sponge material onto which it is affixedso as to not inhibit the intended function or feel of the sponge; (3)ability to be adhered to the surface of gauze surgical sponge materiale.g. by heat pressing so that the material attaches to the spongematerial, in the case of being sewn to the sponge material and/or bystitching through and hold that stitch; (4) ability to be formed and/orshaped, e.g. by die cutting; and (5) ability to hold a color that willcontrast with both a dry sponge (white material with no blood) and wetsponge (white material with blood hence made red in color). Exemplarycolors include blue and purple.

The substrate materials are typically polymer materials which arecombined with radipoage additive, such as barium sulfate. The polymermaterials and additives are selected to give the substrate desiredcharacteristics in its final form. The polymer materials and additivesare mixed and/or blended together and are then extruded into a filmhaving a desired thickness. The film is then cut into desired lengthsand widths and is further cut to allow portions to be removed to formregions in the substrate having a different radiopacity, typically beingradio translucent when the material is cut out and removed entirely. Inother embodiments, the substrate may just be formed with regions whichhave a lesser radiopacity or have a complete absence of radiopaquematerial, but usually cutting and removal will be the most efficienttechnique for forming the radiolucent and radio transparent regions inthe body of the substrate.

In specific examples, the radiolucent and transparent regions will havetwo-dimensional shapes made by removing material from the film. This maybe done by running the film through a customized rotary die cutter whichcuts the desired shaping in the film in a relatively continuous fashion.The shaping may include both cutting and removing material along theedge and the middle of the film. Cutting along the edge may includemaking a saw tooth or wave like pattern. Cutting into the middle of thefilm may include cutting and removing material to create a distinctshape in the middle of the material. By removing material from themiddle of the film that shape will be recognizable under x-ray as thatarea will not include radiopaque materials. Such distinct shape may be acommon geometric or other shape such as a circle, triangle or star. FIG.11A shows an example of shaping the film by cutting and removingmaterial from both the end and middle of the film. The edge regions arecut as a saw tooth pattern while the middle cut-out portions have a starshape. The converted film may be then applied in a continuous fashion tosponge material, or alternatively the film may first may be cut intodesired lengths, as shown in FIG. 11B, and then applied to the gauze orother sponge material in a non-continuous process.

The shaped film is typically affixed to the sponge material using eithera sewing process or a heat press process. In the case of a sewingprocess, the substrate is affixed by stitching the substrate to thesponge material. This can be done in a continuous process (a longsegment of substrate is affixed across sponge material that willsubsequently be cut into multiple sponges) or if the substrate is cutinto a desired length can be done in a non-continuous process (one ormore discrete segments of substrate are attached to sponge material thatwill comprise one sponge).

In the case of a heat press process, the substrate is positioned onsponge material and a combination of heat and pressure are applied so asto melt the substrate (or at least the layer/portion contacting thesponge material) onto the sponge material. This can be done in acontinuous process (a long segment of substrate is affixed across spongematerial that will subsequently be cut into multiple sponges) or if thesubstrate is cut into shorter desired lengths can be done in anon-continuous process (one or more discrete segments of substrate areattached to sponge material that will comprise one sponge). In the caseof a relatively continuous process, the sponge material and shapedsubstrate may be run through rollers (one or both being heated) andpressing against each other at a specific pressure so that thecombination of heat, pressure and speed at which the materials are runthrough the rollers will affix the continuous substrate to the spongematerial. In the case of affixing shorter discrete segments of substrateeither a similar roller based approach can be used or alternatively afixed size heat press head can be applied directly over the segment ofsubstrate and sponge material and held at a certain pressure andtemperature to affix the substrate to the sponge material. One or morediscrete segments of substrate may be applied to sponge materialcomprising one individual sponge.

In the case of the substrate being applied in a relatively continuousprocess (be it via sewing or heat press where a relatively long lengthof shaped substrate is affixed to sponge material to be subsequently cutinto multiple individual sponges), the substrate may be affixed to thesponge material in a varying location on the sponge material, so that,when that sponge material is subsequently cut and folded into individualsponges the substrate will not be folded on top of itself, thusincreasing the surface area of the substrate exposed to be seen underx-ray. If the substrate is applied in a constant location on the uncutsponge material, when cut and folded the substrate may be folded on topof itself and not provide as much exposed surface area to be seen.Examples of varying positions include affixing the substrate to uncutsponge material in an “S” or “V” like pattern.

FIG. 12A is aside view of a continuous sheet of gauze sponge materialand a continuous length of a substrate ribbon being applied and passedthrough opposed heated rollers which affixes the substrate in acontinuous process at varying positions in an “S” pattern. FIG. 12B is atop view of the sponge material and substrate of FIG. 12A being runthrough heated rollers and affixing substrate in a continuous pattern atvarying positions in an “S” pattern.

Comparing FIG. 13 with FIG. 14 shows the benefits of varying theposition of the ribbon relative to substrate when affixing to a singlelayer of sponge material that is later folded multiple times to form afinal sponge. In FIG. 13, the substrate is applied in a fixed position.When folded the substrate is folded upon itself so there is relativelylittle exposed surface area of substrate. In FIG. 14, in contrast, theposition of the substrate is varied into an “S” shape so as to result inmore exposed surface area of substrate when folded into final foldedsponge.

What is claimed is:
 1. A surgical article comprising: a sheet of anabsorbent fabric material configured to absorb body fluid; and a firstplurality of discreet radiopaque elements distributed over at least onedistribution line extending from one edge of the sheet to another edgeof the sheet; wherein the first plurality of discreet radiopaqueelements are arranged in a tethered construct which is attached to thesheet of an absorbent fabric material.
 2. A surgical article as in claim1, wherein tethered construct comprises a flexible elongate member andwherein the plurality of discreet radiopaque elements is secured to theflexible elongate member.
 3. A surgical article as in claim 2, whereinthe flexible elongate member comprises a filament, fiber, thread, orsuture, or wire wherein the plurality of discreet radiopaque elementsare secured over the flexible elongate member.
 4. A surgical article asin claim 2, wherein the tethered construct is molded or extruded to formboth the plurality of discreet radiopaque elements and the flexibleelongate member into an integrated unit.
 5. A surgical article as inclaim 2, wherein the discreet flexible elongate member comprises atubular member and wherein the plurality of discreet radiopaque elementsis secured within the tubular member.
 6. A surgical article as in claim1, wherein the tethered construct is attached to the sheet of anabsorbent fabric material by weaving into the fabric, suturing to thefabric, or heat sealing to the fabric.
 7. A surgical article as in claim1, wherein the sheet of absorbent material is configured to be foldedand individual ones of the discreet radiopaque elements will align withothers of the discreet radiopaque elements to enhance a radiopaque imageartifact when the sheet is in its folded configuration.
 8. A surgicalarticle as in claim 7, wherein the sheet comprises a woven surgicalsponge material.
 9. A surgical article as in claim 7, wherein two halvesof the sheet are folded at least once over along a fold line and whereinthe at least one distribution line crosses over the fold line so thatsome of the plurality of discreet radiopaque elements are on one side ofthe fold line and others of the plurality of discreet radiopaqueelements are on the other side of the fold line after the sheet of theabsorbent fabric material is folded.
 10. A surgical article as in claim9, wherein at least some of the discreet radiopaque elements on one sideof the fold line stack over or near others of the plurality of discreetradiopaque elements on the other side of the fold line after the sheetof the absorbent fabric material is folded.
 11. A surgical article as inclaim 9, wherein at least some of the discreet radiopaque elements onone side of the fold line are interspersed between others of theplurality of discreet radiopaque elements on the other side of the foldline after the sheet of the absorbent fabric material is folded.
 12. Asurgical article as in claim 9, wherein the at least one line isoriented at an acute angle relative to the fold line so that thediscreet radiopaque elements on one side of the fold line and discreetradiopaque elements on the other side of the fold line are oriented in aV-shape relative to each other after the sheet of the absorbent fabricmaterial is folded.
 13. A surgical article as in claim 1, furthercomprising a second plurality of discreet radiopaque elements arrangedin a tethered construct distributed over at least one additionaldistribution line extending from one edge of the sheet to another edgeof the sheet.
 14. A surgical article comprising: a sheet of an absorbentfabric material configured to be folded and to absorb body fluid in thefolded configuration; and a first plurality of discreet radiopaqueelements distributed over at least one distribution line extending fromone edge of the sheet to another edge of the sheet; wherein individualones of the discreet radiopaque elements will align with others of thediscreet radiopaque elements to enhance a radiopaque image artifact whenthe sheet is in its folded configuration.
 15. A surgical article as inclaim 14, wherein the sheet comprises a woven surgical sponge material.16. A surgical article as in claim 15, wherein two halves of the sheetare folded at least once over along a fold line and wherein the at leastone distribution line crosses over the fold line so that some of theplurality of discreet radiopaque elements are on one side of the foldline and others of the plurality of discreet radiopaque elements are onthe other side of the fold line.
 17. A surgical article as in claim 16,wherein at least some of the discreet radiopaque elements on one side ofthe fold line stack over or near others of the plurality of discreetradiopaque elements on the other side of the fold line after the sheetof the absorbent material is folded.
 18. A surgical article as in claim16, wherein at least some of the discreet radiopaque elements on oneside of the fold line are interspersed between others of the pluralityof discreet radiopaque elements on the other side of the fold line. 19.A surgical article as in claim 16, wherein the at least one distributionline is oriented at an acute angle relative to the fold line so that thediscreet radiopaque elements on one side of the fold line and discreetradiopaque elements on the other side of the fold line are oriented in aV-shape relative to each other after the sheet of absorbent material isfolded.
 20. A surgical article as in claim 14, further comprising asecond plurality of discreet radiopaque elements distributed over atleast one additional distribution line extending from one edge of thesheet to another edge of the sheet.